NCT01594320View on ClinicalTrials.gov

A/H5N1 Virus-Like Particle Antigen Dose Ranging Study With Adjuvant 1

PHASE1CompletedINTERVENTIONAL
Enrollment

333

Participants

Timeline

Start Date

April 30, 2012

Primary Completion Date

July 31, 2012

Study Completion Date

August 31, 2013

Conditions
Influenza (Pandemic)
Interventions
BIOLOGICAL

Monovalent Avian Influenza VLP (H5N1)

Dose A without Adjuvant 1; intramuscular, deltoid, Day 0 \& Day 21

BIOLOGICAL

Monovalent Avian Influenza VLP (H5N1)

Dose B without Adjuvant 1; intramuscular, deltoid, Day 0 \& Day 21

BIOLOGICAL

Monovalent Avian Influenza VLP (H5N1); Adjuvant

Dose B with Adjuvant 1; intramuscular, deltoid, Day 0 \& Day 21

BIOLOGICAL

Monovalent Avian Influenza VLP (H5N1); Adjuvant

Dose C with Adjuvant 1; intramuscular, deltoid, Day 0 \& Day 21

BIOLOGICAL

Monovalent Avian Influenza VLP (H5N1); Adjuvant

Dose D with Adjuvant 1; intramuscular, deltoid, Day 0 \& Day 21

BIOLOGICAL

Saline placebo

Placebo; Intramuscular, deltoid, Day 0 \& Day 21

Trial Locations (5)

33026

Broward Research Group, Pembroke Pines

33143

Miami Research Associates, Miami

66219

Johnson County Clin-Trials, Lenexa

78229

Clinical Trials of Texas, San Antonio

92801

Anaheim Clinical Trials, Anaheim

Sponsors

Lead Sponsor

Novavax
All Listed Sponsors
collaborator

Department of Health and Human Services

FED

lead

Novavax

INDUSTRY

NCT01594320 - A/H5N1 Virus-Like Particle Antigen Dose Ranging Study With Adjuvant 1 | Biotech Hunter | Biotech Hunter